Advanced Search

Study Preview



Study Title and Description

Efficacy of topical 5% imiquimod cream for the treatment of nodular basal cell carcinoma: comparison of dosing regimens - 6 Week Study



Key Questions Addressed
1 Comparison of interventions
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Efficacy of topical 5% imiquimod cream for the treatment of nodular basal cell carcinoma: comparison of dosing regimens - 6 Week Study
Author Shumack S., Robinson J., Kossard S., Golitz L., Greenway H., Schroeter A., Andres K., Amies M., Owens M.
Country St George Dermatology and Skin Cancer Center, Level 3, 22 Belgrave St, Kogarah, Australia 2217. sshumack@bigpond.com
Year 2002
Numbers Pubmed ID: 12224977 - 6 week

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 imiquimod (IMQ) 5% cream - Twice daily for 7 days per week
  • Comments Comments (
    0
    ) |
2 imiquimod (IMQ) 5% cream - Once daily for 3 days per week
  • Comments Comments (
    0
    ) |
3 imiquimod (IMQ) 5% cream - Twice daily for 3 days per week
  • Comments Comments (
    0
    ) |
4 imiquimod (IMQ) 5% cream - Once daily for 7 days per week
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
  • Comments Comments (
    0
    ) |
Study design RCT
  • Comments Comments (
    0
    ) |
Multicenter etc. Multicenter
  • Comments Comments (
    0
    ) |
Country/Region Australia and New Zealand; And United States
  • Comments Comments (
    0
    ) |
Funding NR
  • Comments Comments (
    0
    ) |
Inclusion criteria at least 18 years old and had a primary target tumor that was histologically confirmed as nodular BCC. Target tumors suitable for treatment in these 2 studies measured 0.5 to 1.5 cm2 in area and were greater than 1 cm from the eyes, nose, mouth, ear, and hairline.
  • Comments Comments (
    0
    ) |
Exclusion criteria Basal cell carcinomas with morpheic infiltrating and micronodular patterns were excluded from these studies.
  • Comments Comments (
    0
    ) |
N Enrolled/Randomized/Analyzed 99
  • Comments Comments (
    0
    ) |
99
  • Comments Comments (
    0
    ) |
99
  • Comments Comments (
    0
    ) |
Notes/Comments
  • Comments Comments (
    0
    ) |
Method of diagnosis ... Describe Biopsy/pathologic confirmation ... each patient underwent a confirmatory punch or shave biopsy of the target tumor. Investigators were encouraged to use a 2- to 3-mm punch and to remove no more than approximately 25% of the target tumor area. Biopsies extended through the entire depth of the tumor and into the reticular dermis, which was confirmed during the histologic assessment. Biopsy specimens were sent to a central dermatopathology laboratory where they were paraffin processed, stained with hematoxylin and eosin, and microscopically examined for BCC. The presence of a nodular BCC in each biopsy specimen was verified by an independent dermatopathologist.
  • Comments Comments (
    0
    ) |
Preoperative assessment of clinical size of the tumor ... visual ... Target tumors were measured (size ex- pressed as area in square centimeters) and photographed prior to the prestudy biopsy and rephotographed prior to treatment initiation and at each interval visit.
  • Comments Comments (
    0
    ) |
Percent non-primary (recurrent) 0%
  • Comments Comments (
    0
    ) |
Secondary size assessment NR
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question imiquimod (IMQ) 5% cream - Twice daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 3 days per week imiquimod (IMQ) 5% cream - Twice daily for 3 days per week imiquimod (IMQ) 5% cream - Once daily for 7 days per week Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 72 63 69 66 NR
  • Comments Comments (
    0
    ) |
0.6 14.1 11.2 12.4 0.4, 2.6
  • Comments Comments (
    0
    ) |
median area (cm^2) 0.8 0.8 0.8 area in cm^2
  • Comments Comments (
    0
    ) |
median area (cm^2) median area (cm^2) median area (cm^2)
  • Comments Comments (
    0
    ) |
Gender/Racial descent 0 4 4 10 18
  • Comments Comments (
    0
    ) |
0 13 13 29 18.2
  • Comments Comments (
    0
    ) |
Lesion location 1 9 10 4
  • Comments Comments (
    0
    ) |
100 28 32 11
  • Comments Comments (
    0
    ) |
Upper extremity (not hand): 0 Lower extremity (not foot): 0 11 12 17
  • Comments Comments (
    0
    ) |
11.1 39 48
  • Comments Comments (
    0
    ) |
Upper extremity (not hand): 8 (25%) Lower extremity (not foot): 4 (13%) Upper extremity (not hand): 8 (26%) Lower extremity (not foot): 1 (3%) Upper extremity (not hand): 8 (26%) Lower extremity (not foot): 1 (3%)
  • Comments Comments (
    0
    ) |
Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 1 32 31 35 99
  • Comments Comments (
    0
    ) |
NR, but assumed NR, but assumed NR, but assumed
  • Comments Comments (
    0
    ) |
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 1 32 31 35 99
  • Comments Comments (
    0
    ) |
NR NR NR 99
  • Comments Comments (
    0
    ) |
1 4
  • Comments Comments (
    0
    ) |
9 patients were discontinued from the study, but only 4 did not undergo post-treatment excision
  • Comments Comments (
    0
    ) |
95
  • Comments Comments (
    0
    ) |
99
  • Comments Comments (
    0
    ) |
99
  • Comments Comments (
    0
    ) |
4
  • Comments Comments (
    0
    ) |
90
  • Comments Comments (
    0
    ) |
Lesion extent number of people 1 32 31 35 99
  • Comments Comments (
    0
    ) |
1 32 31 35 99
  • Comments Comments (
    0
    ) |
Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure imiquimod (IMQ) 5% cream - Twice daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 3 days per week imiquimod (IMQ) 5% cream - Twice daily for 3 days per week imiquimod (IMQ) 5% cream - Once daily for 7 days per week


6 weeks

N Analyzed 1 32 31 35
Counts 1 13 18 10
Outcome: Adverse events: other      Population: All Participants
Time Point Measure imiquimod (IMQ) 5% cream - Twice daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 3 days per week imiquimod (IMQ) 5% cream - Twice daily for 3 days per week imiquimod (IMQ) 5% cream - Once daily for 7 days per week


6 weeks

N Analyzed 1 32 31 35
Counts NR 13 18 10
Outcome: Adverse events: other      Population: All Participants
Time Point Measure imiquimod (IMQ) 5% cream - Twice daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 3 days per week imiquimod (IMQ) 5% cream - Twice daily for 3 days per week imiquimod (IMQ) 5% cream - Once daily for 7 days per week


6 weeks

N Analyzed 1 32 31 35
Counts NR NR NR 1
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure imiquimod (IMQ) 5% cream - Twice daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 3 days per week imiquimod (IMQ) 5% cream - Twice daily for 3 days per week imiquimod (IMQ) 5% cream - Once daily for 7 days per week


6 weeks

N Analyzed 1 32 31 35
Counts 1 NR NR NR


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes 99 patients randomized to Imiquimod and placebo according to the dosing scheme: - once daily for 3 days per week (32) -twice daily for 3 days per week (31) - once daily for 7 days per week (35) - twice daily for 7 days per week (1)
  • Comments Comments (
    0
    ) |
RCT:....Adequate allocation concealment reported No Data
  • Comments Comments (
    0
    ) |
RCT:....Adequate blinding of PATIENTS reported Yes
  • Comments Comments (
    0
    ) |
RCT:....Adequate blinding of PROVIDERS reported No Data
  • Comments Comments (
    0
    ) |
ALL....Adequate blinding of OUTCOME ASSESSORS reported No Data
  • Comments Comments (
    0
    ) |
ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? No
  • Comments Comments (
    0
    ) |
ALL.....Selective Reporting (judgement - put directly into notes field). No
  • Comments Comments (
    0
    ) |
RCT.....Is the treatment effect by Intention to treat? Yes 9 patients were discontinued from the study, but only 4 did not undergo post-treatment excision 5 of 99 enrolled did not undergo post treatment excision. ITT not reported.
  • Comments Comments (
    0
    ) |
ALL....Group similarity at baseline. No Noticeable difference in age for Twice daily for 7 days/ week arm (n=1)
  • Comments Comments (
    0
    ) |
ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) Yes The arm, "Twice daily for 7 days / week" only contains n=1, compared to the 3 other arms which have n= 21-24
  • Comments Comments (
    0
    ) |
ALL (with AE results)....Were reported adverse events (of interest) precisely defined Yes
  • Comments Comments (
    0
    ) |
Overall, by outcome (judgement - put directly into notes field) Low RoB Adverse events reported but not for every arm
  • Comments Comments (
    0
    ) |
ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No
  • Comments Comments (
    0
    ) |

Quality Rating
Guideline Used Overall Rating